Current Status of Treatment for Chinese Patients With ESR1-mutated HR+/HER2-advanced Breast Cancer

Launched by SCICLONE PHARMACEUTICALS · Aug 7, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how well different treatments work for women with advanced breast cancer that has a specific genetic change called an ESR1 mutation. The study will involve women who have already tried hormone therapy without success. By observing how these patients respond to various treatments, researchers aim to gather important information about the effectiveness and safety of these options in real-life settings.

To be eligible for this trial, participants must be women aged 18 and older who are postmenopausal and have been diagnosed with advanced breast cancer that cannot be treated with surgery or radical radiotherapy. They should also have confirmed ESR1 mutations and have experienced progression after at least one type of hormone therapy. Throughout the study, participants will have regular check-ups every 2-3 months to monitor their health and treatment response until their cancer progresses or they start a new treatment. This trial is currently recruiting participants, and those interested should talk to their healthcare provider for more information.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. must have a histologically or cytologically confirmed diagnosis of breast cancer with evidence of locally advanced disease unsuitable for excision or radical radiotherapy, or evidence of metastatic disease unsuitable for radical treatment.
• • 2. female ≥ 18 years of age
• • 3. female subjects must be postmenopausal (meeting any of the following criteria is sufficient) a) Has undergone oophorectomy. b) Age ≥ 60 years. c) 40 years old \< age ≤ 60 years old with 1 year of menopause. d) Age \<60 years and receiving ovarian suppression therapy.
• • 4. ER-positive and HER2-negative status and ESR1-mutation positive must be confirmed.
• • 5. must have progressed on at least one line of endocrine therapy prior to enrollment, including monotherapy or combination therapy.
• • 6. have normal organ function (as assessed by the investigator).
• Exclusion Criteria:
• • 1. women who are pregnant or breastfeeding
• • 2. known difficulties in tolerating oral medications, or conditions that interfere with the absorption of oral medications or allergies to medications and their excitements
• • 3. other conditions that make enrollment in the study unsuitable, at the discretion of the investigator